Active — Not RecruitingPhase 1/2

NT-101 Topical Ophthalmic Solution in Patients With Wet AMD

United States30 participantsStarted 2025-03-11

Plain-language summary

Phase 1/2 Trial NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD)

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject who is male or female ≥ 50 years of age at Screening.
✓. Choroidal neovascularization (CNV) lesions secondary to AMD that affected the central subfield in the study eye that meets the following criteria at Screening:
✓. BCVA between 25 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.
✓. Either no previous treatment in the study eye with anti-VEGF therapy (treatment naïve) or previously treated study eye with adequate washout from the baseline visit as defined below:
✓. Demonstrate the ability to instill eye drops (by the subject or caregiver) in the study eye, express willingness to comply with the dosing regimen, and commit to attending all study visits.
✓. Understands and voluntarily signs an informed consent form.
✓. Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or agree to practice two acceptable methods of contraception throughout the course of the study and 3 months after their last study administration. Acceptable methods of contraception include :

✕. Subject who has the following illness or abnormal laboratory test values at
✕. Other clinically significant abnormal lab values per Investigator's judgement.
✕. Subject who has a medical condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including psychiatric disorder, cardiovascular disease, poor glycemic control, and significant medical condition including end-stage renal disease and severe liver diseases).
✕. History of stroke or myocardial infarction within 6 months prior to Screening.
✕. Subject who has had major surgery within 3 months prior to Screening.
✕. Pregnant or breastfeeding or intended to become pregnant during the study.
✕. Subject with known hypersensitivity to any active substance or excipients of the investigational product, fluorescein, dilating eye drops, or any of the anesthetic and antimicrobial drops.
✕. Treatment with investigational therapy or participation in any other type of interventional trial within 30 days before Screening.

Number and Severity of Treatment-Emergent Adverse Events (TEAEs) up to Week 8

Timeframe: 8 weeks

NCT IDNCT06704009

SponsorNexThera Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-15

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject who is male or female ≥ 50 years of age at Screening.
✓. Choroidal neovascularization (CNV) lesions secondary to AMD that affected the central subfield in the study eye that meets the following criteria at Screening:
✓. BCVA between 25 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.
✓. Either no previous treatment in the study eye with anti-VEGF therapy (treatment naïve) or previously treated study eye with adequate washout from the baseline visit as defined below:
✓. Demonstrate the ability to instill eye drops (by the subject or caregiver) in the study eye, express willingness to comply with the dosing regimen, and commit to attending all study visits.
✓. Understands and voluntarily signs an informed consent form.
✓. Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or agree to practice two acceptable methods of contraception throughout the course of the study and 3 months after their last study administration. Acceptable methods of contraception include :

✕. Subject who has the following illness or abnormal laboratory test values at
✕. Other clinically significant abnormal lab values per Investigator's judgement.
✕. Subject who has a medical condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including psychiatric disorder, cardiovascular disease, poor glycemic control, and significant medical condition including end-stage renal disease and severe liver diseases).
✕. History of stroke or myocardial infarction within 6 months prior to Screening.
✕. Subject who has had major surgery within 3 months prior to Screening.
✕. Pregnant or breastfeeding or intended to become pregnant during the study.
✕. Subject with known hypersensitivity to any active substance or excipients of the investigational product, fluorescein, dilating eye drops, or any of the anesthetic and antimicrobial drops.
✕. Treatment with investigational therapy or participation in any other type of interventional trial within 30 days before Screening.